Aurobindo subsidiary Eugia gets FDA approval for Cyclophosphamide Injection

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Aurobindo Pharma said that its subsidiary Eugia Pharma Specialities has secured approval from the (FDA) for the new drug application for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials.

Cyclophosphamide Injection is indicated in the US for malignant lymphomas, , neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, leukemias, mycosis fungoides, and carcinoma of the breast.

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The Indian pharma company said that the drug will be available in ready-to-use (RTU) injection preparation. It will be rolled out in the near term in the US market and will be manufactured at Eugia Pharma Specialities’ facility in .

According to IQVIA, cyclophosphamide has an addressable market size of $170 million for the 12 months ending June 2021.

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Cyclophosphamide Injection is the 19th product for to be approved for Eugia Pharma Specialities, while taking ‘s ANDA approvals from the FDA to 482.


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